Reversing Abortion Pill: Can It Be Done?

A new group of anti-abortion physicians may have 'the antidote' for RU-486.

What happens when a woman takes the RU-486 pill and then changes her mind?

In 2009, George Delgado, MD, medical director at Culture of Life Family Health Care and the regional medical director of The Elizabeth Hospice, a nonprofit hospice in San Diego, Calif., received a phone call from a pro-life friend and "sidewalk counselor" about a patient in El Paso, Texas. The patient had taken RU-486 (mifepristone) and immediately regretted the decision.

"I started thinking about my years of experience with progesterone, and how I'd used progesterone to try to prevent miscarriage," Delgado said at the American Association of Prolife Obstetricians and Gynecologists (AAPLOG) conference on Saturday.

Today, Delgado is the medical director of Abortion Pill Reversal (APR), a network of 235 doctors across the country who offer an off-label, experimental treatment aimed at reversing abortion.

Progesterone is a critical hormone during pregnancy, said Delgado. It helps nourish the placenta, keeps the cervix closed, and inhibits contractions.

Mifepristone, a progesterone receptor antagonist, acts like a "false key" binding with the progesterone receptor and blocking its activity. This action softens the cervix, makes the uterine wall more vulnerable to contractions, and attacks the placenta, Delgado said.

"I thought, well, maybe we can out compete [mifepristone] at the receptor [using progesterone]," he said.

Experimenting

Delgado found a doctor near El Paso who had progesterone and was willing to try an experimental treatment, involving injectable progesterone.

He recommended a protocol to the physician and "lo and behold, it worked," he said.

Soon after the procedure, Delgado began receiving more phone calls about reversing medical abortion. So he started studying the pharmacology of mifepristone and learned of another physician, Matthew Harrison, MD, who had performed the first documented RU-486 reversal in 2007.

Mifepristone was licensed by the FDA in 2000. According to this report, as of 2008, nearly a quarter of the abortions prior to 9 weeks in the U.S. -- that's around 800,000 a year -- were completed using mifepristone.

Providers learned that using mifepristone alone sometimes resulted in incomplete abortions where the uterus does not "empty." So they began giving patients misoprostol after 2 days, to trigger uterine contractions and "expel the baby," Delgado said. This gives physicians a window for intervention of about 2 days. Although some patients have received the reversal treatment after more than 2 days.

Contraindications for the progesterone therapy include ectopic pregnancies and women who have had a reaction to progesterone in the past, Delgado said. He recommends an ultrasound before giving the progesterone, or within a day or two after.

Using Delgado's first case, Harrison's case and several others, Delgado and Mary Davenport, MD, an obstetrician gynecologist in private practice in San Francisco and AAPLOG president from 2011 to 2013, published a report in the Annals of Pharmacotherapy in December 2012.

The article included six case reports of women who used progesterone therapy to attempt to reverse abortions. Four of the six women who used mifepristone only and then progesterone gave birth to "healthy term newborns" according to the report. In the two other cases the abortion was completed shortly after the progesterone injections. The report acknowledged a seventh patient, who did not respond to requests to follow-up and was afterwards excluded.

Delgado said patients are told that the use of progesterone in this context is not FDA approved, that it isn't 100% effective, and that they may have side effects such as sleepiness, heartburn, and aching legs. With injectable progesterone, patients are told there is a small risk of bleeding a the injection site.

According to the protocol described in the report, patients should be given 200 mg of progesterone intra muscularly as soon as possible after taking mifepristone. They should also have an ultrasound examination as soon as possible to confirm fetal viability. Providers should repeat the progesterone injections daily for 2 days, then every other day until 13 days after taking mifepristone, and continue twice each week for the full first trimester.

In three of the four births, there were no neonatal complications or birth defects. One baby had jaundice and a circumcision wound infection, the report noted.

"We believe that if further trials confirm the success without complications of this or similar protocols, it should become the standard of care for obstetrician-gynecologists, family physicians, and emergency department physicians to attempt mifepristone reversal on patient request," the authors concluded.

As of Dec. 31 2014, Delgado has found a 57% success rate with the Abortion Pill Reversal treatment. Of the 223 women who have received progesterone, 127 cases succeeded, according to a fact sheet Delgado shared. These successes include documented births, women who are still pregnant, and those "lost to contact" after 20 weeks, he said.

The fact sheet noted that all of the babies were "normal at birth."

Future of RU-486 Reversal

Daniel Grossman, MD, a fellow of the American Congress of Obstetricians and Gynecologists and vice president for research at Ibis Reproductive Health in Oakland, Calif., said that based on the 2012 case studies series,"there is really no clear evidence that this works."

For about 30% to 50% of women who take mifepristone alone, the pregnancy will continue, he said.

"In the rare situation where a women takes a mifepristone and then changes her mind, it may very well be that doing nothing and just waiting to see what happens would be just as effective as doing this course of progesterone treatment."

Grossman was also concerned that the research was done without the oversight of an institutional review board or an ethical review committee of some kind.

"If women are being asked to pay for this treatment without any evidence of its effectiveness, I would say that's also very concerning."

At this time, the treatment isn't one that the ACOG would recommend, he said.

Delgado said that some insurance companies have covered the cost of the treatment and that benefactors have also offered to pay. He has not heard of anyone who has been denied treatment due to finances.

In an email, Delgado said that ACOG was "biased" and that institutional review board is not required to follow cases. "As we gather more and more data, what will ACOG say then?"

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